The invention relates generally to drug delivery devices. Specifically, the present invention relates to the tracking and identification of an individual prescription drug delivery device, such as an adhesive patch, and involves encoding the drug delivery device with pertinent information.
While there is no limitation on the type of drug that can be used with the present invention, the invention has particular applicability for “controlled substances” such as those listed in the regulations promulgated pursuant to the Food, Drug and cosmetic Act, 21 C.F.R. §§ 1308 et seq., and include substances having a stimulant or depressant effect on the central nervous system. Because stimulant drugs have a high potential for abuse, the U.S. Drug Enforcement Administration (DEA) has placed stringent controls on their manufacture, distribution and prescription. For example, the DEA requires special licenses for these activities.
One such prescription stimulant drug is methylphenidate (MPH). MPH, manufactured and sold by Novartis Pharmaceuticals Corporation (formerly Ciba-Geigy) under the brand name Ritalin®, is used in the treatment of attention deficit and/or hyperactivity disorders in both children and adults. Experts estimate that such disorders affect 3.5 million children and 17 million adults—and perhaps even as much as 10 percent of the American population. MPH helps individuals suffering from such disorders stay calm and focused, and often improves their behavior, grades and even their self esteem. About 1.5 million school-age youngsters have been prescribed MPH in mid-1995, with more recent estimates climbing to about 2.4 million.
However, use for illicit, non-medicinal purposes is being increasingly reported particularly among college and high school students. In 1994, a national high school survey (Monitoring the Future) indicated that non-prescription use of MPH doubled among high school seniors between 1993 and 1994, resulting in more seniors abusing MPH than are actually prescribed it legitimately. Similar to cocaine or amphetamines in the nature and duration of their effects, abusers are crushing Ritalin® tablets into powder which they then snort to get a quick high.
Diversion or abuse of MPH is not however limited to students. Diverse segments of the population from health care professions to street addicts have also been implicated. Organized drug trafficking groups are using various schemes to obtain MPH for resale on the illicit market. According to the DEA, MPH ranks among the most frequently reported controlled pharmaceuticals stolen from licensed handlers.
Law enforcement and other authorities confiscate prescription drugs and specifically, controlled substances, from unauthorized users or unlicensed handlers. It would be useful, to be able to identify the specific product, such as the individual drug delivery device, and be able to trace the origin of that specific product to determine the identity of the last licensed handler of the product, the prescribing physician, pharmacy or patient, etc. Currently, there is no way to identify the ownership or trace the origin of a prescription drug once it is removed from the prescription packaging.
The art has recognized the need for improving record keeping and inventory management in dispensing drugs, and various methods have (been employed by health care suppliers that include drug dispensing machines. US, WO 98/28676 disclosed a method for drug information management that utilizes a drug dispensing machine in combination with a computerized drug management software system. The method provides for removing the original drug packaging, and re-packaging the drug into a container that is then marked in order to identify information regarding or relating to the repackaged contents. The new container containing the one or more repackaged drugs is then dispensed from an automated machine which is in electronic communication with a computer in order to track drug use and need for replacement.
Presumably, if a legitimate handler believes that the individual prescription drugs it dispenses can be traced back to him or her, the handler will be less inclined to distribute the drug illegally and will take greater precautions against loss or theft. The criminal penalties for illegal distribution and use of controlled substances are severe. Thus, providing authorities with a system for accurately identifying the last known legitimate handler of or other pertinent information regarding a particular prescription drug product would help to reduce the potential for abuse and illegal distribution of the product. It would also make available more of the supply of the drug for use by legitimate users with a medical need.
Placing the drug in a delivery system that can control the release rate of the drug in the body or to a site of application, such as an adhesive patch, can help to reduce the potential for abuse of the drug over other conventional dosage administration forms. Nevertheless, the potential for abuse and misuse still exists even with the use of such patches.